NCT02159534

Primebrain Stimulation

Multicentric Prospective Randomised Single-blind Controlled Clinical Study Assessing the Effect and the Safety of Primebrain Sensorimotor Stimulation on Neurological Development of Preterm Infants (Born Before 32 Weeks' Gestation) or Infants Born Weighing Less Than 1500 g

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Queen Fabiola Children's University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Background : Brain vulnerability is particularly marked in preterm neonates and has long-term consequences. Unlike lesions affecting other organs, those that affect the brain can currently not 'be repaired' by producing new cells. However, exeprience-driven brain plasticity allows the brain to reorganise its connections to compensate (at least partially) the effects of an injury. Purpose : To evaluate the influence of Primebrain stimulation programme administred by parents until 6 months post-term on motor and neurophysiological development of infants born \<32 weeks' gestation or with birth weight \<1500 g.

Detailed description

Preterm and very low birth weight infants are at risk for neurodevelopmental disorders, including cerebral palsy, sensory impairment and intellectual disability. Several early intervention approaches have been designed in the hope of optimising neurological development in this context. These programmes show high variety in the type of intervention, frequency of sessions and total duration of the intervention, as well as the duration of follow-up. Depending on studies, there is an inconstant benefit on cognitive and behavioural development in the first 2 years and preschool age. According to the most recent studies, it seems important that the intervention takes into account parental mental health, focuses on parent-child interactions and lasts sufficiently long. This prospective randomized-controlled clinical study has been designed to evaluate the effects of an additional parent-administed programme to the usual care in this developmental risk population,. The intervention is carried out at home by parents coached by physiotherapist from term-age to 6 months of corrected age. The monitoring and evaluation period for all infants participating in the study ends at 24 months of corrected age and includes clinical, neurodevelopmental, parental stress and neurophysiological assessments using high density electroencephalography and recording of event-related potentials at term age, 3, 6, 12 ,18 and 24 months of corrected age (ActiveTwo, BioSemi).

Conditions

• Preterm Infants

Interventions

Type	Name	Description
OTHER	Primebrain	Primebrain stimulation programme aims to facilitate the infant's self-organization of postural competences by proposing varied sensorimotor experiences in a context supporting parent-child interaction.

Timeline

• Start date: 2014-09-01
• Primary completion: 2020-02-01
• Completion: 2020-09-01
• First posted: 2014-06-10
• Last updated: 2019-02-15

Locations

1 site across 1 country: Belgium